Senior Director

Senior Director, In Vivo Pharmacology

Location : South San Francisco, CA

A venture backed early stage highly innovative biopharmaceutical company that has developed a novel ultrasound-guided non-viral gene therapy platform to provide patients with the next generation of genetic medicines.

Our platform can precisely and non-invasively target almost any organ in the body to deliver very large payloads of diverse formats (DNA, RNA, and combinations thereof) that provide durable expression with the ability to re-dose and dose titrate and without off-target delivery.

Our corporate culture is driven by a collaborative, interdisciplinary, and forward-thinking approach to solving many of the current challenges facing genetic medicine discovery and drug development.

Job Summary :

The successful candidate will be an essential part of the Research team focusing on the design, implementation, and oversight of in vivo pharmacology studies leading to successful FDA IND application(s) for ultrasound mediated gene therapy programs.

The position will lead the research staff within the in vivo team. The job will require collaboration with cross functional partners to manage resource allocations to enable portfolio progression.

Projects requiring pharmacology support may span from platform development, target validation, preclinical development, to translational biology.

What You Will Accomplish :

• Provide leadership focusing on platform innovation and preclinical program development that leads to successful FDA IND application(s) for gene therapy drug candidates.
• Management of in-vivo pharmacology studies, including design, implementation, conduct and reporting structure.
• Facilitate the conceptualization and development of innovative research strategies and plans for preclinical studies aligned with the company's therapeutic portfolio and goals.
• Identifying, assess, and oversee various contract research organizations (CRO’S) to complement internal capabilities and generate critical pharmacokinetic, pharmacodynamic, and efficacy data.
• Investigate and initiate innovative approaches to identify appropriate pre-clinical and clinical biomarkers.
• Foster effective collaboration and communication with internal teams, external partners, and key stakeholders to ensure alignment of research objectives and facilitate knowledge sharing.
• Perform independent investigational research within the field of study to provide leadership to advance optimization of the in vivo research methodologies, technologies, and industry trends.
• Develop and present Pharmacology strategy, plans and data at project team meetings and to management to support project objectives.
• Support the filing of regulatory documents, including preparation of final study reports and IND (or related) documents
• Contribute to a team culture that promotes collaboration, open communication, career development, excellence, ownership, curiosity, and inclusion.

Qualifications :

• MD / PhD in Molecular & Cell Biology, Genetics, Biochemistry, Immunology, Physiology or related areas.
• Minimum 15 years of experience designing, executing, and overseeing in vivo pharmacology studies to support projects in the pharmaceutical or biotech industry.
• Previous experience managing in vivo pharmacology studies in an industry setting, with experience in overseeing non-GLP and GLP studies is required.
• Minimum 10 years of experience managing teams and cross-functional projects, preferably in the gene therapy field.
• Experience in generating and managing pre-IND reports is strongly preferred.
• Prior experience with gene therapy platforms is strongly preferred.
• Previous experience working in fast paced start-up environments preferred.

Technical Requirements and Skills :

• Strong technical expertise in study design methodologies, a wide range of in vivo disease models and in vivo techniques including imaging.
• A strategic thinker with the ability to analyze possibilities, evaluate the benefits / risks as well as mitigation strategies and solutions.
• Strong leadership, program management skills, including experience in building, leading and developing strong and collaborative scientific teams.
• Strong communication skills, with the ability to effectively collaborate with cross-functional teams and external partners.
• Demonstrated ability to stay updated with the latest advancements and trends in in vivo research.
• Must be proactive and able to work effectively on multiple projects in a fast-paced, dynamic environment.
• Strong written and verbal communication skills.

Benefits

We thrive to give you the tools to feel healthy, happy and secure.

• Equity and ownership in a fast-growing company.
• Access to a 24-hour gym
• Comprehensive medical, dental, and vision
• Commuting stipend based on your geographical location
• 401(k) Match : We offer a dollar-for-dollar match
• All full-time employees are eligible for our flexible time off policy
11 days ago